Status:
UNKNOWN
Metastatic Thyroid Cancer Therapy Optimization With 124I PET Dosimetry
Lead Sponsor:
Carlo Chiesa
Collaborating Sponsors:
Associazione Italiana per la Ricerca sul Cancro
Conditions:
Metastatic Differentiated Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Failure of conventional radioiodine therapy of metastatic differentiated thyroid cancer could be explained by: * a suboptimal therapeutic approach, based on the administration of empirically fixed am...
Detailed Description
TRIAL DESIGN This is a one-stage, phase II, single-arm, bi-centric study. Enrollment centres are the Istituto Nazionale Tumori in Milan, and the Sacro Cuore Don Calabria Hospital in Negrar, close to ...
Eligibility Criteria
Inclusion
- Histo-pathological diagnosis of DTC
- At least one documented non surgically-curable soft-tissue metastasis previously untreated
- ECOG performance status = 0 - 1
- Life expectancy \> 6 months
- Females of childbearing age must have negative serum pregnancy test prior to registration and agree to use birth control throughout the study and for 6 months after completion of therapy
- Preserved hematologic and renal function (hemoglobin \> 10 g/dL; WBC \> 3500/uL; neutrophils \> 50%; PLT \> 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL)
- Signed informed consent
Exclusion
- All lesions surgically resectable
- Minimal lymph nodal disease (diameter \< 1 cm, up to 2 nodes)
- Patient with skeletal metastases only
- Lung diffuse miliary micro-metastases
- Ongoing pregnancy
- Breast-feeding (enrollment could be considered after suspension)
- Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy
- Impossibility to undergo follow-up procedures
- Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects' ability to complete the protocol
- Assumption of any anti-tumor therapy including chemotherapy, biological or investigational drug treatments
- Assumption of any myelotoxic drugs
- Previous or concomitant assumption of Amiodarone
- Any other oncologic disease that required treatment in the last 5 years.
- Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug.
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05299437
Start Date
May 12 2021
End Date
September 30 2024
Last Update
March 29 2022
Active Locations (2)
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1
Nuclear Medicine, Ospedale Sacro Cuore - Don Calabria
Negrar, Verona, Italy, 37129
2
Nuclear Medicine, Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy, 20133